Download UNDP-WBMSC-08

WEST BENGAL MEDICAL SERVICES CORPORATION LIMITED
Through
United Nations Development Programme, New Delhi.
Invitation to Bid (ITB)
SUPPLY OF NEONATAL VENTILATORS FOR HOSPITALS AND MEDICAL COLLEGES
OF THE GOVERNMENT OF WEST BENGAL
ITB: UNDP-WBMSC-08-2014
Amendment-II, dated 14 May, 2014
The following amendments are hereby made to the Bid document for the SUPPLY OF
NEONATAL VENTILATORS FOR HOSPITALS AND MEDICAL COLLEGES OF THE
GOVERNMENT OF WEST BENGAL, with reference to above ITB:
Reference:
Wherever appearing in the bid document, the date, time and venue for receiving /
opening of bids shall be read as:
Last Date, Time and Place
of Receiving of Bids
1300 Hrs. (IST) on May 23, 2014
Date, Time and Place
of Bid Opening
1430 Hrs. (IST) on May 23, 2014
at United Nations Development Programme (UNDP),
55, Lodhi Estate, New Delhi-110003.
at United Nations Development Programme (UNDP),
55, Lodhi Estate, New Delhi-110003.
Section 3a - Schedule of Requirements and Technical Specifications are hereby replaced
as in Annexure below of this Amendment.
Section 7 – Price Schedule form is hereby replaced as in annexure below of this
amendment
All other terms and conditions of the bid document, except as amended herein above,
remain unaltered.
United Nations Development Programme,
55, Lodhi Estate, New Delhi – 110 003.
Tel: 91 11 2462 8877
Email : [email protected]
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Annexure
Section 3a: Schedule of Requirements and Technical
Specifications
List of Goods and Consignee:
Schedule
No.
1
Description of Goods
Neonatal Ventilator
Quantity
(in
number)
52
Bid Security in
INR
Bid Security in
USD
10,00,000.00
16,000
Consignee – Hospitals and Medical Colleges of Govt. of West Bengal
i.
Delivery to Consignee within 30 days from the date of issue of the Purchase OrderContract.
ii.
Installation, Training & Commissioning:
Satisfactory Installation, Training & Commissioning as per the Consignee list above within 15
days from the respective dates of delivery of the goods.
Note: While installation at the designated site/location and commissioning will be the
responsibility of the supplier, basic readiness of the site enabling such installation will be the
responsibility of the consignee
Supplier should provide onsite training, monitor effectiveness of training and take corrective
actions as and when required by WBMSCL / end user during the warranty period after the
installation of the equipment.
The successful bidder will have to set up service centre in West Bengal and submit proper
document in support within 15 days of receipt of Award of Contract (AOC).
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Technical Specifications
Schedule - 1
Neonatal Ventilator
A. ESSENTIAL
1. A neonatal ventilator must have all these components below:











Ventilator
Integrated display unit and user interface
Air Compressor (Ventilator should be compressor driven).
Reusable Circuit
Servo Humidifier
Nebulizer (integrated or standalone)
Proximal flow / volume sensor
Stand for circuits
External battery backup (for ventilator, monitor, humidifier and compressor)
Operator manual
Service Manual
2. Type of ventilator:
Advanced microprocessor based Continuous flow, time cycled, pressure limited ventilator
capable of ventilating Newborns weighing ≤ 500 grams.
3. Modes
Nasal CPAP, Non-invasive ventilation, IMV (IPPV), SIMV, Assist/Control (A/C), pressure
supported ventilation (with backup ventilation).
4. Range of set parameters
Parameters
Essential
Non-invasive modes

NCPAP pressure / PEEP
3 - 10

Apnea alarm while on NCPAP
Must

PIP (NIV) – cm of H2O
10 – 50

Inspiratory time (NIV) – sec
0.2 – 2.0
Invasive Modes

Peak inspiratory pressure (cm of H2O)

Positive and expiratory pressure (cm of 3 – 10
H2O)
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
10 – 50
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
Fraction of inspired oxygen (%):
21-100%

Inspiratory time (sec)
0.2 – 2.0

Rate (per min)
20-120

Tidal volume (ml)
2-100

Trigger
Flow
5. Display unit / User interface:
LED/LCD - TFT monitor with 10” or higher digital display
Display of following set parameters:






Airway pressures(PIP, PEEP)
FiO2
Rate
Ti, Te, I:E ratio
Tidal Volume
Minute Volume
Display of following measured parameters:










Airway pressures (PIP, PEEP, MAP)
FiO2
Ti, Te, I:E ratio
Tidal Volume
Minute Volume
Compliance
Resistance
Leak percentage
Alarm message
Graphics – Scalars (pressure, volume, flow)/
Loop (pressure-volume, flow volume)
a) 3 waves-Pressure, volume and flow with time,
b) 2 loops – P-V, F-V with facility of saving of 1 (one) Loop for reference
6. Alarms (Audio & Visual)







Power / mains failure
Compressor failure
O2 not connected / pressure low
Air not connected
MV low / high
Leak alarm / low tidal volume
Flow sensor not connected
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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





Flow sensor not calibrated
Oxygen too high
Oxygen too low
Low & High pressure
High / low respiratory rate
Apnea alarm
7. Humidifier
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
ix.
x.
xi.
Capable of working with both invasive and non-invasive mode
Must conform to ISO 8185
Should be capable of always supplying fully saturated gas at 37°C
Flow resistance <20 cm H2O/L/sec(Ins R<12, Exp R < 8)
Temperature range 31-400 C
Temperature control ± 2°C
Digital display of temperature – 5-80°C
Capable of ambient humidity compensation
Should be compatible with both reusable & disposable chambers and circuits
Must have water level indicator
Minimum Warm up time (<30 min)
8. Medical Air Compressor
a)
b)
c)
d)
e)
Imported standalone or in-built or integrated, USFDA and CE approved.
Oil free Medical Air Compressor, not turbine generator
Air quality should comply with ISO 8573.1 compressed air purity class 1.4.1
Air Compressor should automatically be activated in the event of wall air supply loss
Replacement of filters should be performed without removing the compressor (inbuilt)
f) Low noise
9. Nebulizer
(i) Purpose : aerosolized drug delivery while intubated.
(ii) Technique : Ultrasonic / vibrating mesh technology
(iii) Standalone / Integrated with pre-installed software and to be supplied with required reusable
nebulization chamber or unit along with tubing, cable and adapter / accessories for
nebulization.
(iv) Particle size (MMD): ≥2µm ≤5µm
10. Proximal flow / volume sensor
(i) Type : flow sensor / volume sensor
(ii) Dead space :≤1 ml
(iii) TV : 0.5 – 200 ml
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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(iv) If reusable, costs for required sensors and cable for a total of 5 years are to be included in the
quoted price of the equipment. Quoted CMC price should include cost for required sensors and
cable during CMC period.
(v) If disposable, costs of required units for a total of 5 years (approx.. minimum 150 per year)
are to be included in the quoted price of the equipment. Quoted CMC price should include cost
of required units (approx. 150 per year) during CMC period. Supply of disposables will be in a
staggered manner as per the demand of the end – user.
11. FiO2 / Oxygen cell
Cost of the cells during the warranty period should be included in the quoted price of the equipment
and that during the CMC period should include in the quoted CMC price.
12. Environmental factors
1. The unit shall be capable of being stored continuously in ambient temperature of 0-60
deg C and relative humidity of <95%.
2. The unit should be capable of operating continuously in ambient temperature of 10-40
deg C and relative humidity of 15-90%.
3. Shall meet IEC-60601-1-2:2001 (Or Equivalent BIS) General Requirements of Safety
for Electromagnetic Compatibility.
13. Power supply with back-up power
1. Power input to be 220-240VAC, 50Hz
2. Resettable over current breaker shall be fitted for protection
3. Suitable UPS (for humidifier, Compressor and Ventilators) with maintenance free
batteries for minimum one-hour back-up should be supplied with the system.
14. Standards, safety and training
a) Certified to be compliant with ANS/IEC 60601.2.12-01 Medical Electrical
Equipment – Part 2-12. Should be US FDA and CE approved product.
b) Certified to be compliant with ISO-7767 for Oxygen monitoring.
c) Should meet IEC 529 Level 3 (IP3X) (spraying water) for enclosure protection,
water ingress.
d) Demonstration of quoted equipment model is a must.
e) Should have local service facility. The service provider should have the necessary
equipment recommended by the manufacturer to carry out preventive maintenance
test as per guidelines provided in the service/maintenance manual.
f) Warranty for 5 years and provision of CMC for next 5 years
15. Spares with each Ventilator*
* Price of the spares listed below are to be quoted separately along with the bid. The
bidder should ensure the availability of spares for another 5 years after the completion
of warranty & CMC.
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Modular corrosion free original trolley
1 unit
Silicon patient circuit with WYE piece for neonates
5 sets
Servo controlled humidifier, with digital temperature display reusable chamber 1 unit
and capable of working in both invasive and non-invasive modes
Reusable humidifier chamber
5 such
Nasal CPAP Disposable Circuit
10sets
Temperature probe & adaptor (Humidifier)
5 such
Heater wire (Humidifier)
5 such
Heater wire adaptor (Humidifier)
5 such
Flow sensor cable if reusable
3 such
Flow sensor if reusable
3 such
Flow sensor if disposable (number per year at least)
150 sets
Nebulizer – Integrated / standalone
1set
Stand for patient circuit
2 such
Test lung for each ventilator
1 set
Hose for O2 connection (for wall connection)
5 metres
Hose for compressed air (for wall connection)
5 metres
Nasal mask and prongs (three different sizes)
2 sets each
Expiratory valve / block per ventilator
2 units
Low noise air compressor
1 unit
Washable external air filters for compressor
2 sets
Expiratory Cassette / membrane
10 units
16. Documentation
(i)
(ii)
Certified of calibration and inspection from factory
List of Equipment available for providing calibration and routine maintenance
support as per manufacturer documentation in service/technical manual
(iii) User Manual in English
(iv) Service manual in English
(v)
Log book with instructions for daily, weekly, monthly and quarterly maintenance
checklist. The job description of the hospital technician and company service
engineer should be clearly spelt out.
(vi) List of important spare parts and accessories with their part number and costing.
(vii) Compliance Report to be submitted in a tabulated and point wise manner clearly
mentioning the page/para number of original catalogue/date sheet. Any point, if
not substantiated with authenticated catalogue/manual, will not be considered.
(viii) Must submit user list and performance report within last 5 years from major
hospitals.
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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B. DESIRABLES
17. Desirable Parameter versus allotted marks
Range versus allotted marks
Maximum
allotted
marks
Parameters
Volume ventilation*
High frequency ventilation*
Oxygen sensor (longer life at least > 5 years)
Record / trends saving
NCPAP pressure / PEEP (cm of H2O)
Inspiratory time (sec) in TCPL
Tidal volume (ml)
User friendliness
5
Range of parameters
Allotted marks
Available & integrated
5
Upgradable
3
Not upgradable
1
Upgradable
5
Not upgradable
1
Available & integrated
5
Not available
1
≤24 hours
1
> 48 hours & integrated
3
3 to 15
3
3 to 25
2
3 to > 25
1
0.10 to 2.0
7
0.10 to > 2.0
3
0.20 to ≥ 3.0
1
2 to 100
15
2 to 150
10
2 to 200
5
2 to > 200
1
User interface & ease in
operation. Compactness of
whole system including
compressor, Graphics etc.
12
5
5
3
3
7
15
12
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Maximum
allotted
marks
Parameters
Range versus allotted marks
Range of parameters
Proximal flow / volume sensor
Allotted marks
Reusable &autoclavable
7
Disposable
1
Integrated / In-built
5
Imported standalone
1
Vibrating mesh technique
3
Ultrasonic
1
±3%
6
±5%
3
>±5%
1
±3%
6
±5%
3
>±5%
1
±3%
6
±5%
3
>±5%
1
± 0.5 ml (< 5 ml)
6
± 1.0 ml (<5 ml)
1
FiO2 (±4%) < 30 sec
3
FiO2 (±4%) > 30 sec
1
Circuit disconnection < 0.1 sec
3
Circuit disconnection > 0.1 sec
1
7
Air compressor
5
Nebulizer
3
6
6
PIP
PEEP
Accuracy
6
FiO2
6
TV
3
Alarm delay (support with manual)
3
Total

100
Bidders will have to quote the cost for up-gradation separately. The same shall be
considered during bid evaluation.
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Important Note:
Equipment will be considered technically qualified if,
1. Conform with all essential specifications mentioned in A (ESSENTIAL) ; and
2. Secure at least 80 marks out of 100 in B (DESIRABLES) of the technical specifications.
Bidders are requested to keep one unit of the offered model along with all the accessories ready for a
functional demonstration to be scheduled at Kolkata immediately after the bid opening at a short
notice. The exact date, venue and time will be intimated to all the preliminarily qualified bidders
separately by the Bid Evaluation Committee.
Company should have local service facility (Details to be provided in following format)
Sl. No.
Name and
address of the
service center (s)
Sl. No.
Name of Service
Engineer
Phone Nos.
Fax No.
Mobile Number
e-mail address
No. of Service
engineers
Location
Toll Free No. (if any) :
Name of Service Head :
Mobile Number :
The service provider should have the necessary equipment recommended by the manufacturer
to carry out preventive maintenance test as per guidelines provided in the service/maintenance
manual, but at least once in three months during the warranty and CMC period.
One CD/DVD of demonstration video must be supplied with the equipment for end users.
Warranty for 5 years and CMC for 5 years after warranty. The prices for CMC shall be quoted at
the time of tendering process. The Prices of CMC shall be considered for the evaluation process.
The offered Warranty includes the cost of labour for all repairs; all spares & accessories required for
replacement during repairs which forms part of the equipment system, without which it cannot
perform satisfactorily.
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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The successful bidder will have to set up its own service centre in West Bengal and submit proper
documents in support within 15 days of receipt of Award of Contract (AOC).The manufacturer will
also have to set up their regional office in West Bengal.The service provider should have the
necessary equipment recommended by the manufacturer to carry out preventive maintenance test
as per guidelines provided in the service/maintenance manual.
NOTE :
1) Reusable consumables should last during the warranty period.
2) In case any additional reusable consumables are required during the warranty period those
will be supplied free of charge by the supplier.
3) The life expectancy of the reusable consumable is expected to be of at least one year from the
date of purchase of the same. The reusable consumables will be procured at the prices
accepted as per the contract.
4) Any reference to brand / product, in case it occurs anywhere in the technical specification is
purely for indicative/illustrative purposes and should be read as including its equivalent.
5) Unless specified otherwise in the Technical Specifications, all offers should include UPS unit
or battery backup of at least one hour, as the case may be, with each equipment.
6) Offered product catalogue to be attached in original (2 in nos.) with each bid.
7) Attach valid quality certification document(s); no self-certifications admissible.
8) Product quality standard (CE/US FDA) to be supported by authentic documents; Warranty, its
scope and service facilities to be clearly indicated in the documents.
9) One CD/DVD of demonstration video must be supplied with the equipment for end users.
10) One CD/DVD of demonstration video must be submitted along with the bid.
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Section 7: Price Schedule Form1
The Bidder is required to prepare the Price Schedule as indicated in the Instruction to Bidders. The Bidders are requested to provide the cost of the goods
(inclusive of all tax/duty, excluding entry tax) for each Schedule quoted in the following format.
SCH.
No.
(a)
BRIEF DESCRIPTION OF GOODS
(b)
QTY.
(c)
1
Neonatal Ventilator – Quoted price should include
a) cost of Proximal flow / volume sensors & cable (if
reusable) for a total of 5 years of warranty [OR]
b) cost of Proximal flow / volume sensors & cable (if
disposable) for a total of 5 years of warranty (approx.
minimum 150 per year) AND
c) cost of FiO2 / Oxygen cell for a total of 5 years of
warranty
Cost for the up gradation of Volume ventilation, if
applicable
Cost for the up gradation of High frequency ventilation,
if applicable
52
MAKE/MODEL
NO. &
COUNTRY OF
ORIGIN
(d)
CURRENCY
(e)
UNIT PRICE
DDP (Incoterm
2010) FINAL
DESTINATION
(all inclusive) (f)
52
52
Note: Quoted CMC price should include
a) cost of Proximal flow / volume sensors & cable (if reusable) [OR]
b) cost of Proximal flow / volume sensors & cable (if disposable, approx. minimum 150 per year) AND
c) Cost of FiO2 / Oxygen cell
CMC Charges for Year1 after completion of 5 years warranty
CMC Charges for Year2 after completion of 5 years warranty
1
52
52
No deletion or modification may be made in this form. Any such 1deletion or modification may lead to the rejection of the Bid.
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TOTAL PRICE DDP
(Incoterm 2010) FINAL
DESTINATION (all
inclusive)
(g) = (c) x (f)
CMC Charges for Year3 after completion of 5 years warranty
52
CMC Charges for Year4 after completion of 5 years warranty
52
CMC Charges for Year5 after completion of 5 years warranty
52
* DDP Price final destination shall include all the cost incidental to delivery at final destination including all duties & taxes to be paid.
* DDP Price of the above equipment shall include Supply and Installation, Commissioning and warranty for Equipment.
** There shall be no exemption from any applicable tax or duty;
*** Entry tax @ 1% of cost of goods is applicable which will be reimbursed.
NOTE : The following points with regard to consumables should be noted while bidding for the schedule:‐
1.
2.
3.
Reusable consumables should last during the warranty period.
In case any additional reusable consumables are required during the warranty period those will be supplied free of charge by the supplier.
The life expectancy of the reusable consumable is expected to be of at least one year from the date of purchase of the same. The reusable
consumables will be procured at the prices accepted as per the contract.
4.
5.
The price excluding CMC quoted in one schedule should be in one currency only.
If CMC column is left blank, then it will be assumed that the CMC is free of cost.
Important:‐
 Bidders will have to quote the cost for up-gradation separately. The same shall be considered during bid evaluation.
Proximal flow / volume sensor:
(i) If reusable, costs for required sensors and cable for a total of 5 years are to be included in the quoted price of the equipment. Quoted CMC price should
include cost for required sensors and cable during CMC period.
(ii) If disposable, costs of required units for a total of 5 years (approx.. minimum 150 per year) are to be included in the quoted price of the equipment.
Quoted CMC price should include cost of required units (approx. 150 per year) during CMC period. Supply of disposables will be in a staggered manner as
per the demand of the end – user.
FiO2 / Oxygen cell:
Cost of the cells during the warranty period should be included in the quoted price of the equipment and that during the CMC period should include in the
quoted CMC price.
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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Spares:
* Price of the spares listed below are to be quoted separately along with the bid. The
bidder should ensure the availability of spares for another 5 years after the completion of
warranty & CMC.
Item
Unit Price
(Delivery at final
destination)
Modular corrosion free original trolley
Silicon patient circuit with WYE piece for neonates
Servo controlled humidifier, with digital temperature display
reusable chamber and capable of working in both invasive and
non‐invasive modes
Reusable humidifier chamber
Nasal CPAP Disposable Circuit
Temperature probe & adaptor (Humidifier)
Heater wire (Humidifier)
Heater wire adaptor (Humidifier)
Flow sensor cable if reusable
Flow sensor if reusable
Flow sensor if disposable (number per year at least)
Nebulizer – Integrated / standalone
Stand for patient circuit
Test lung for each ventilator
Hose for O2 connection (for wall connection)
Hose for compressed air (for wall connection)
Nasal mask and prongs (three different sizes)
Expiratory valve / block per ventilator
Low noise air compressor
Washable external air filters for compressor
Expiratory Cassette / membrane
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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BIDDER’S DISCOUNT FOR ACCELERATED PAYMENT
____% of total firm price for each calendar day less than thirty (30) days
BIDDER'S SIGNATURE AND CONFIRMATION OF THE ITB
PROVIDED THAT A PURCHASE ORDER IS ISSUED BY UNDP WITHIN THE REQUIRED BID VALIDITY PERIOD, THE UNDERSIGNED HEREBY
COMMITS, SUBJECT TO THE TERMS OF SUCH PURCHASE ORDER, TO FURNISH ANY OR ALL ITEMS AT THE PRICES OFFERED AND TO DELIVER
SAME TO THE DESIGNATED POINT(S) WITHIN THE DELIVERY TIME STATED IN SCHEDULE OF REQUIREMENT.
Exact name and address of company
COMPANY NAME
ADDRESS
PHONE NO.
AUTHORIZED SIGNATURE
FAX NO.
DATE
NAME OF AUTHORIZED SIGNATORY (TYPE OR PRINT)
EMAIL ADDRESS OF CONTACT PERSON
FUNCTIONAL TITLE OF SIGNATORY
OTHER EMAIL ADDRESSES
WEB SITE
Amendment – II – ITB : UNDP‐WBMSC‐08‐2014
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